Specialist add-on · Toolkit G
Combination Product / Device Interface Add-On
Extend the core system with combination-product planning, human factors, complaint-to-PV interfaces, risk management, and pathway controls.
What it helps control
Operational support
Helps drug-device teams connect human-factors, complaint, safety, and regulatory evidence across both product components.
How it helps your team
Add product-specific controls without rebuilding the core development system.
Designed for
Combination-product, device, clinical, human-factors, Quality, Pharmacovigilance, and Regulatory Affairs teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Combination Product Development Plan
- Human Factors Study Plan
- Device Complaint-PV Interface SOP
- Combination Product Risk Management Plan
- Device/Drug Regulatory Pathway Assessment
Excel workbooks
- Device Complaint Tracker
- Human Factors Study Tracker
- Combination Product Risk Register
- Device-PV Reconciliation Tracker
- Combination Product Evidence Matrix
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